In the phase III historically controlled Children’s Oncology Group (COG) AAML0631 trial, arsenic trioxide consolidation permitted the use of lower-dose anthracycline without appearing to compromise outcomes in pediatric patients with acute promyelocytic leukemia (APL). The results were...
PRIMARY LIVER CANCER is the second leading cause of cancer-related death worldwide. Hepatocellular carcinoma accounts for 90% of liver cancer, with around 800,000 new cases diagnosed globally each year.1 In contrast to the stable or declining trends observed for most neoplasms, the incidence and...
ALTHOUGH THE National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) strongly influence the management of advanced prostate cancer, they do not always reflect actual clinical practice. It turns out that in the real world, there are multiple areas ...
THE ADDITION of daratumumab (Darzalex) to a triplet induction regimen led to good responses in newly diagnosed multiple myeloma, but not without toxicities. And in the treatment of myeloma bone disease, denosumab (Xgeva) in place of zoledronic acid preserved renal function and may be associated...
IMMUNOTHERAPY AND ANTIANGIOGENESIS were highlighted in a session on metastatic non–small cell lung cancer (NSCLC) at the Best of ASCO New Orleans meeting. Matthew Gubens, MD, MS, presented the selected abstracts from the ASCO Annual Meeting.1 Dr. Gubens is Associate Professor of Thoracic Medical...
Older adults continue to be proportionally underrepresented in oncology clinical trials, but the participation rate of adults aged 65 and older is increasing by “slow, incremental changes,” Stuart M. Lichtman, MD, FACP, FASCO, noted in an interview with The ASCO Post. Prompting those changes are...
On August 15, Bristol-Myers Squibb Company announced topline results from the CheckMate-214 trial investigating nivolumab (Opdivo) in combination with ipilimumab (Yervoy) vs sunitinib (Sutent) in intermediate- and poor-risk patients with previously untreated advanced or metastatic renal cell...
On August 16, the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for brentuximab vedotin (Adcetris) in patients with cutaneous T-cell lymphoma (CTCL). The sBLA and its acceptance is based on data from the phase III...
The U.S. Food and Drug Administration (FDA) recently granted approval, expanded approval, and breakthrough therapy designation to numerous treatments across a range of tumor types and malignancies. New Drug Approvals Daunorubicin-Cytarabine Combination (Vyxeos): On August 3, the FDA granted...
This past fall, the Fred Hutchinson Cancer Research Center in Seattle opened an all-encompassing 9,222-square foot outpatient cellular immunotherapy clinic, specifically designed to serve patients participating in the center’s novel immunotherapy clinical trials, which mainly focus on chimeric...
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on patients with stage II or III colorectal cancer. These studies highlight dietary intervention, supplements, immunotherapy, combination chemotherapy, neoadjuvant therapy, and...
Triple-negative breast cancer has a reputation for being a particularly challenging malignancy, but breast cancer specialist Nancy Davidson, MD, Senior Vice President of the Clinical Research Division at the Fred Hutchinson Cancer Research Center, Seattle, put this in perspective in a recent...
The French phase III ALLOZITHRO trial, stopped early due to excessive hematologic relapse in the azithromycin group, showed worse airflow decline–free survival with azithromycin vs placebo after hematopoietic stem cell transplantation (HSCT) for hematologic malignancy. The study findings were ...
The UK IMPORT LOW phase III trial has shown noninferiority in local relapse for partial-breast and reduced-dose vs standard whole-breast radiotherapy after breast-conserving surgery in early breast cancer. These study results were reported by Coles et al in The Lancet. Study Details In the...
The phase III FIRSTANA trial has shown no difference in overall survival with two dose regimens of cabazitaxel (Jevtana) vs docetaxel in the first-line treatment of metastatic castration-resistant prostate cancer. Results were reported by Oudard et al in the Journal of Clinical Oncology....
As reported in The Lancet by Tewari et al, the final overall survival results of the phase III Gynecologic Oncology Group (GOG) 240 trial show continued benefit of the addition of bevacizumab (Avastin) to chemotherapy in patients with metastatic, persistent, or recurrent cervical carcinoma. Study...
In a health-related quality-of-life study among patients in the phase III TOAD trial, immediate vs delayed androgen-deprivation therapy was associated with early worsening of androgen-deprivation therapy–related symptoms but few other comparative adverse effects on functioning or quality of...
In the phase III DATA trial reported in the Journal of the National Cancer Institute by van Hellemond et al, 12% of women with breast cancer who had chemotherapy-induced ovarian function failure experienced ovarian function recovery during 30 months of aromatase inhibitor therapy with anastrozole....
NEW DRUGS that will improve the outcome of adult patients who develop a deadly disease such as acute leukemia are badly needed; combinations of cytotoxic chemotherapeutic drugs may have reached an upper limit of utility. Agents that eradicate leukemia by alternative mechanisms would be of...
IN THE PHASE III TOWER TRIAL reported in The New England Journal of Medicine, Hagop Kantarjian, MD, of The University of Texas MD Anderson Cancer Center, and colleagues found that blinatumomab (Blincyto) treatment improved overall survival vs chemotherapy in heavily pretreated patients with B-cell ...
ANAPLASTIC LYMPHOMA KINASE (ALK) was first identified in anaplastic large cell lymphoma. The ALK gene itself is not oncogenic, but it can become oncogenic by at least three mechanisms: by forming a fusion gene with a number of other partner genes, by copy number gain, or by mutations in the gene....
Today, the U.S. Food and Drug Administration (FDA) accepted Genentech’s supplemental New Drug Application (sNDA) and granted Priority Review for alectinib (Alecensa) as a first-line treatment for people with anaplastic lymphoma kinase (ALK)-positive, locally advanced, or metastatic...
The following essay by Howard A. (Skip) Burris III, MD, is adapted from The Big Casino: America’s Best Cancer Doctors Share Their Most Powerful Stories, which was coedited by Stan Winokur, MD, and Vincent Coppola and published in May 2014. The book is available on Amazon.com and thebigcasino.org....
On July 27, it was announced that the phase III FLAURA trial showed a statistically significant and clinically meaningful progression-free survival benefit with osimertinib (Tagrisso) compared to current first-line standard-of-care treatment (erlotinib [Tarceva] or gefitinib [Iressa]) in previously ...
A phase III trial (SOLO2/ENGOT-Ov21) has shown improved progression-free survival with an olaparib tablet formulation vs placebo as maintenance therapy in patients with BRCA1/2-mutant platinum-sensitive relapsed ovarian cancer. These study results were reported by Pujade-Lauraine et al in The...
The oncology community has now conducted several prospectively designed, hypothesis-driven randomized clinical trials among women with breast cancer to address this question: Do adjuvant bisphosphonates decrease the risk of breast cancer bone metastases and other recurrence? A meta-analysis1 by...
WITHIN THE SPECTRUM of breast cancer subtypes, triple-negative disease is “particularly troubling,” but better scientific understanding of this malignancy is leading to advances in its treatment, according to breast cancer expert Nancy Davidson, MD. Triple-negative breast cancer does not express...
THE 22ND CONGRESS of the European Hematology Association (EHA) was held in June in Madrid, drawing hematologists and allied professionals from every subspecialty of hematology from around the world. Among the extensive educational and scientific program, the EHA Congress provides a forum for...
RESULTS OF the IDEA trial, which showed that some patients with stage III low-risk colon cancer may require less oxaliplatin therapy (see the June 25 issue of The ASCO Post), were among the findings highlighted at the 2017 ASCO Annual Meeting Plenary Session. Other studies of interest in colorectal ...
FRANK SINICROPE, MD, Professor of Oncology and Co-Leader of the GI Cancer Program at the Mayo Clinic, Rochester, said CHARTA addressed whether patient outcomes can be improved with a triplet regimen plus bevacizumab (Avastin) vs a standard doublet plus bevacizumab. This was based upon the finding...
DURING JULY, the U.S. Food and Drug Administration (FDA) and its Oncologic Drugs Advisory Committee (ODAC) made a number of approvals and recommendations on a variety of oncology products. Neratinib ON JULY 1 7, the FDA approved neratinib (Nerlynx) for the extended adjuvant treatment of adult...
MOST ONCOLOGISTS are familiar with the findings of the plenary sessions featured at the 2017 ASCO Annual Meeting, with topics ranging from the duration of adjuvant oxaliplatin-based therapy in stage III colon cancer to patient-reported outcomes for symptom monitoring during routine cancer...
THE BODY OF EVIDENCE supporting the use of cell-cycle inhibitors in combination with endocrine therapy for estrogen receptor–positive metastatic breast cancer now has another agent in the spotlight. The phase III MONARCH 2 trial—reported at the 2017 ASCO Annual Meeting and by Sledge et al in the...
The ASCO Post is pleased to continue this special feature on the worldwide cancer burden. Each installment focuses on a country from one of the six regions of the world, as defined by the World Health Organization (ie, Africa, the Americas, South-East Asia, Europe, Eastern Mediterranean, and...
New recommendations on the use of the MammaPrint genomic test issued on July 10 will help guide decisions on adjuvant systemic therapy for women with early breast cancer. The recommendations update the ASCO 2016 clinical practice guideline on the use of biomarkers in these patients. The guideline ...
On July 27, IBM Watson Health and Quest Diagnostics announced the launch of IBM Watson Genomics from Quest Diagnostics, a new service that helps advance precision medicine by combining cognitive computing with genomic tumor sequencing. Memorial Sloan Kettering Cancer Center (MSK) will...
The 10-year follow-up of the phase III TEAM trial has shown that exemestane alone and sequential tamoxifen/exemestane provide similar outcomes as adjuvant endocrine therapy in postmenopausal women with hormone receptor–positive early breast cancer. The findings were reported in The Lancet...
In the randomized phase IIB DETERMINE trial, the cytotoxic T-lymphocyte–associated protein 4 (CTLA-4) inhibitor tremelimumab did not improve overall survival vs placebo as second- or third-line treatment of relapsed malignant mesothelioma. These findings were reported in The Lancet Oncology...
On July 26, the European Commission (EC) approved fulvestrant (Falsodex) for the treatment of estrogen receptor–positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy. The EC approval is based on pivotal data from the...
On July 31, AstraZeneca and MedImmune (AstraZeneca’s global biologics research and development arm) announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for durvalumab (Imfinzi) for the treatment of patients with locally advanced,...
In the phase IB KEYNOTE-029 study, standard-dose pembrolizumab (Keytruda) plus reduced-dose ipilimumab (Yervoy) produced high response rates in patients with advanced melanoma. These results were reported by Long et al in The Lancet Oncology. Study Details In the study, 153 patients with...
On July 27, researchers announced the progression-free survival (PFS) results for the phase III MYSTIC trial, a randomized, open-label, multicenter, global trial of durvalumab (Imfinzi) monotherapy or durvalumab in combination with tremelimumab vs platinum-based standard-of-care chemotherapy in...
Today, the U.S. Food and Drug Administration (FDA) expanded the indication for ipilimumab (Yervoy) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. Ipilimumab was evaluated in 2 trials of pediatric...
For patients with advanced, inoperable stage III lung cancer, concurrent chemotherapy and proton-beam radiotherapy offers improved survival compared to historical data for standard of care, according to a new study from The University of Texas MD Anderson Cancer Center. The research, published by...
In an Italian phase III trial reported by Locatelli et al in The Lancet Oncology, a lower vs higher dose of rabbit anti–T-lymphocyte globulin (ATLG) was associated with a nonsignificantly greater incidence of acute graft-vs-host disease but better event-free and overall survival in children...
WITH THE RECENT efficacy findings, improvements in survival, and resultant U.S. Food and Drug Administration (FDA) approvals of programmed cell death protein 1 (PD-1) immune checkpoint inhibitors across multiple solid tumor indications, the publication of yet another positive trial adds to the...
THE TREATMENT OF metastatic urothelial carcinoma experienced a long period of stagnation until the recognition that targeting the programmed cell death protein 1 (PD-1) pathway could yield deep and durable responses.1-3 Cisplatin-based combination chemotherapy has been the reference standard for...
The phase III NRG Oncology RTOG 0436 trial has shown no survival benefit of adding cetuximab (Erbitux) to paclitaxel/cisplatin and radiation therapy in patients with esophageal cancer treated without surgery. These results were reported by Suntharalingam et al in JAMA Oncology. Study Details In...
IN THE PHASE III KEYNOTE-045 trial reported in The New England Journal of Medicine, Joaquim Bellmunt, MD, PhD, of Dana-Farber Cancer Institute, and colleagues found that pembrolizumab (Keytruda) significantly improved overall survival vs investigator choice of chemotherapy as second-line treatment ...
FOR PATIENTS WITH BREAST CANCER who have metastases to the central nervous system (CNS), clinicians should think twice before administering whole-brain radiotherapy, according to Kimberly Blackwell, MD, Professor of Medicine and Assistant Professor of Radiation Oncology at Duke University Medical...